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How do I track recruitment of research participants?

It is your responsibility to regularly monitor recruitment in your research project, including composition of participants. Your yearly progress report must include an Inclusion Enrollment Report Form which shows the cumulative accrual of your participants. In addition, NHLBI has developed a policy to establish milestones in studies. Terms and Conditions for Accrual of Research Subjects in Research describes the partnership between you and the NHLBI to ensure adequate enrollment and timely project completion.

Regardless of the mechanism of support, NHLBI staff will closely monitor progress during your award. Monitoring may include regular communications with you and your research staff. The Terms and Conditions of Award for a clinical trial will include recruitment milestones expected to be met by centers at specific time periods, accrual goals for women, children, and minorities (as appropriate), any requirements regarding minimum effort of specific investigators, and any other identified requirements for completion of the approved research. As with any award, continuation, even during the period recommended for support, is conditional upon satisfactory progress. If, at any time, recruitment falls significantly below the projected milestones for recruitment, NHLBI may consider ending support and negotiating a phase-out of the award.

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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